Purpose of this Study
In this study, patients will first receive either the study drug or a placebo for 24 weeks. After that, everyone in the study will receive the real drug for 28 weeks. The whole study will last about 60 weeks. Each person will need to come to the clinic nine times during the study. All visits will take place at the South Durham Clinic.
Who Can Participate?
Eligibility
People can join this study if they are at least 18 years old. They must have active lichen planopilaris that is rated as moderate or severe. They also need to have a biopsy that shows they have this condition, and the biopsy can be up to five years old. Their weight must be more than 40 kilograms and less than 130 kilograms, and their body mass index must be lower than 45.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The ALPINE study wants to find out if a medicine called brepocitinib can help control a condition called lichen planopilaris. The medicine is a pill that people take once each day. The study will also compare how well the medicine works when compared to a placebo, which is a pill that has no medicine in it.
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Lichen Planopilaris
Principal Investigator
Anne
Marano
Protocol Number
PRO00119603
Phase
II/III
Enrollment Status
Pending Open to Enrollment